Workshop: Early Development & Valorisation

Topic 1: Regulatory aspects and GxP

Vladimir Pucovsky, Scientific Administrator, EMA Europe

• How does the new animal health law stimulate innovation in animal health
• EMA’s innovation task force services and regulatory guidance
• When is GxP relevant/required?
• Can industry provide regulatory guidance?
• Tips & tricks

Topic 2: Technology offer and matchmaking

Hervé Poulet - Director of Strategic Partnering, Boehringer-Ingelheim Animal Health

What information should a technology offer contain: what does industry
want and what can innovators provide?

• Importance of data on mode of action, efficacy, safety, market potential
  and regulatory aspects.
• At what stage can collaboration start and how can this be funded?

Topic 3: Valuation and Deal-Making

Lourdes Mottier - Elanco & Sven Arnouts - University of Ghent (Provaxs)

• Cost of goods and manufacturing: at what stage should this be considered?
• The cost structure of the development process: from discovery to MAA
• Valuation of innovative and ground-breaking technologies:
• What if benchmarking is not possible?
• Should it be risk-adjusted?
• Deal structure
• Default elements of the deal
• Differences in function of TRL of the asset